ECL-DONEPEZIL TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

DONEPEZIL HYDROCHLORIDE

Disponibbli minn:

ECL PHARMA GROUP LTD

Kodiċi ATC:

N06DA02

INN (Isem Internazzjonali):

DONEPEZIL

Dożaġġ:

10MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

DONEPEZIL HYDROCHLORIDE 10MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

30/100/500

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

PARASYMPATHOMEMETIC (CHOLINERGIC) AGENTS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0131548002; AHFS:

L-istatus ta 'awtorizzazzjoni:

CANCELLED (UNRETURNED ANNUAL)

Data ta 'l-awtorizzazzjoni:

2018-03-23

Karatteristiċi tal-prodott

Page 1 of 50
PRODUCT MONOGRAPH
Pr
ECL-DONEPEZIL
donepezil hydrochloride Tablets, In House
5 and 10 mg
CHOLINESTERASE INHIBITOR
ECL Pharma Group Limited
Date of Revision:
1100 Central Parkway W 38-2
May 12, 2015
Mississauga, Ontario L5C 4E5
Control # 184171
Page 2 of 50
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
3
ADVERSE REACTIONS
...................................................................................................
7
DRUG INTERACTIONS
.................................................................................................
16
DOSAGE AND ADMINISTRATION
.............................................................................
17
OVERDOSAGE
...............................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 18
STORAGE AND STABILITY
.........................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 21
PART II: SCIENTIFIC INFORMATION
...............................................................................
22
PHARMACEUTICAL INFORMATION
.........................................................................
22
CLINICAL TRIALS
.........................................................................................................
24
DETAILED PHARMACOLOGY
....................................................................................